Abstract：
Infection with the hepatitis D virus (HDV) causes the most severe form of viral hepatitis with a high risk to develop clinical complications of liver disease. In addition, hepatitis delta has been shown to be associated with worse patient-reported outcomes. Until recently, only pegylated interferon alfa could be used to treat hepatitis delta.
Here, we investigated quality of life (QOL) as assessed by the Short Form 36 Health Survey (SF-36) in patients undergoing antiviral therapy with pegylated interferon alfa (PEG-IFNa-2a)-based treatment in the HIDIT-II trial. HIDIT-II was a randomized prospective trial exploring PEG-IFNa-2a with tenofovir disoproxil (TDF) or placebo for 96 weeks in patients with compensated hepatitis delta. Surveys completed by 83 study participants before, during, and after treatments were available.
Overall, we observed a reduced QOL of HDV patients compared with a reference population, both in physical as well as mental scores. Interestingly, PEG-IFNa-2a treatment showed only minor impairment of the QOL during therapy. Moreover, HDV-RNA clearance was not associated with relevant changes in physical or social SF-36 scores, whereas an improvement of fibrosis during treatment was associated with increased QOL. Overall, slight improvements of the QOL scores were observed 24 weeks after the end of treatment as compared with baseline. TDF co-treatment had no influence on QOL.
Overall, our findings suggest that PEG-IFNa-2a was reasonably tolerated even over a period of 96 weeks by hepatitis D patients reporting SF-36 questionnaires. Of note, several patients may benefit from PEG-IFNa-2a-based therapies with off-treatment improvements in quality of life.
Here, we investigated quality of life (QOL) as assessed by the Short Form 36 Health Survey (SF-36) in patients undergoing antiviral therapy with pegylated interferon alfa (PEG-IFNa-2a)-based treatment in the HIDIT-II trial. HIDIT-II was a randomized prospective trial exploring PEG-IFNa-2a with tenofovir disoproxil (TDF) or placebo for 96 weeks in patients with compensated hepatitis delta. Surveys completed by 83 study participants before, during, and after treatments were available.
Overall, we observed a reduced QOL of HDV patients compared with a reference population, both in physical as well as mental scores. Interestingly, PEG-IFNa-2a treatment showed only minor impairment of the QOL during therapy. Moreover, HDV-RNA clearance was not associated with relevant changes in physical or social SF-36 scores, whereas an improvement of fibrosis during treatment was associated with increased QOL. Overall, slight improvements of the QOL scores were observed 24 weeks after the end of treatment as compared with baseline. TDF co-treatment had no influence on QOL.
Overall, our findings suggest that PEG-IFNa-2a was reasonably tolerated even over a period of 96 weeks by hepatitis D patients reporting SF-36 questionnaires. Of note, several patients may benefit from PEG-IFNa-2a-based therapies with off-treatment improvements in quality of life.
摘要：
目的：丁型肝炎病毒（HDV）感染是最严重的病毒性肝炎，具有发生肝病临床并发症的高风险。此外,丁型肝炎已被证明与患者报告的预后较差相关.直到最近,只有聚乙二醇干扰素α可用于治疗丁型肝炎。
方法：这里，我们调查了在HIDIT-II试验中接受基于聚乙二醇化干扰素α(PEG-IFNa-2a)的抗病毒治疗的患者的生活质量(QOL)。HIDIT-II是一项随机前瞻性试验，探索PEG-IFNa-2a与替诺福韦酯（TDF）或安慰剂在代偿性丁型肝炎患者中96周。之前由83名研究参与者完成的调查，during,治疗后可用。
结果：总体而言，与参考人群相比，我们观察到HDV患者的QOL降低，无论是在身体上还是在心理上。有趣的是,PEG-IFNa-2a治疗在治疗期间仅显示QOL的轻微损害。此外，HDV-RNA清除与身体或社会SF-36评分的相关变化无关，而治疗期间纤维化的改善与QOL的增加相关。总的来说,治疗结束后24周,与基线相比,QOL评分略有改善.TDF联合治疗对QOL无影响。
结论：总体而言，我们的研究结果表明,报告SF-36问卷的丁型肝炎患者,即使在96周的时间内,PEG-IFNa-2a的耐受性也是合理的.值得注意的是，一些患者可能受益于基于PEG-IFNa-2a的治疗,且非治疗改善了生活质量.
方法：这里，我们调查了在HIDIT-II试验中接受基于聚乙二醇化干扰素α(PEG-IFNa-2a)的抗病毒治疗的患者的生活质量(QOL)。HIDIT-II是一项随机前瞻性试验，探索PEG-IFNa-2a与替诺福韦酯（TDF）或安慰剂在代偿性丁型肝炎患者中96周。之前由83名研究参与者完成的调查，during,治疗后可用。
结果：总体而言，与参考人群相比，我们观察到HDV患者的QOL降低，无论是在身体上还是在心理上。有趣的是,PEG-IFNa-2a治疗在治疗期间仅显示QOL的轻微损害。此外，HDV-RNA清除与身体或社会SF-36评分的相关变化无关，而治疗期间纤维化的改善与QOL的增加相关。总的来说,治疗结束后24周,与基线相比,QOL评分略有改善.TDF联合治疗对QOL无影响。
结论：总体而言，我们的研究结果表明,报告SF-36问卷的丁型肝炎患者,即使在96周的时间内,PEG-IFNa-2a的耐受性也是合理的.值得注意的是，一些患者可能受益于基于PEG-IFNa-2a的治疗,且非治疗改善了生活质量.
